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Post-MI PET Scan Imaging of Inflammation

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ClinicalTrials.gov Identifier: NCT02281305
Recruitment Status : Unknown
Verified October 2014 by Spyridon Deftereos, G.Gennimatas General Hospital.
Recruitment status was:  Recruiting
First Posted : November 3, 2014
Last Update Posted : November 3, 2014
Sponsor:
Collaborator:
Academy of Athens
Information provided by (Responsible Party):
Spyridon Deftereos, G.Gennimatas General Hospital

Study Description
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Brief Summary:
Restoring the patency of the coronary vessels and providing the ischemic myocardium with reperfused blood can cause additional tissue damage. A key element of ischemia and reperfusion (I/R) injury and major determinant of the evolution of damage in the affected myocardium is the inflammatory response. The main objective of the study is to evaluate the efficacy of colchicine in reducing I/R injury by effectively modulating the inflammatory response in the reperfused myocardium.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Drug: Colchicine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Imaging of Inflammation in the Postischemic Myocardium: Effect of Anti-inflammatory Treatment With Colchicine
Study Start Date : October 2014
Estimated Primary Completion Date : April 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Colchicine Active treatment group
Drug: Colchicine 2 mg loading dose; 0.5 mg bid for 5 days
 Drug: Colchicine
Placebo Comparator: Control group
Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Degree of inflammation of the involved myocardium as assessed by the PET scan [ Time Frame: 5 days post-MI ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The study will enroll patients 18 years old or older
  • Who presented to the hospital within twelve (12) hours of the onset of chest pain -Who had ST segment elevation > 1 mm in two contiguous limb leads or ST segment elevation > 2 mm in two consecutive precordial leads or new onset of left bundle branch block (LBBB) in a twelve lead electrocardiogram and for whom the decision was made to be taken to the cath lab to perform angioplasty of the coronary vessels.

Exclusion Criteria:

  • Excluded patients:

    • with age > 80 years old
    • with active inflammatory diseases, infectious diseases or known malignancy
    • under treatment with corticosteroids, anti-inflammatory agents or disease modifying agents
    • with known hypersensitivity-allergy to colchicine
    • under chronic treatment with colchicine
    • with severe renal failure (eGFR < 30 ml/min/1.73 m2)
    • with hepatic failure (Child - Pugh class B or C)
    • presented with cardiac arrest
    • presented with ventricular fibrillation
    • presented with cardiogenic shock
    • with stent thrombosis
    • with angina within 48 hours before infarction
    • with previous myocardial infarction in the affected territory
    • with occlusion of the left main or left circumflex coronary or the right coronary artery or with evidence of coronary collaterals to the region at risk on initial coronary angiography (at the time of admission)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02281305


Contacts
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Contact: Spyridon Deftereos, MD +302107768560 spdeftereos@gmail.com
Contact: Georgios Giannopoulos, MD +302107768560 ggiann@med.uoa.gr

Locations
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Greece
Athens General Hospital "G. Gennimatas" Recruiting
Athens, Attika, Greece, 11527
Contact: spyridon Deftereos, MD    +302107768560    spdeftereos@gmail.com   
Sponsors and Collaborators
G.Gennimatas General Hospital
Academy of Athens
Investigators
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Principal Investigator: Constantinos Anagnostopoulos, MD Biomedical Research Foundation of Academy of Athens
Principal Investigator: Christos Angelidis, MD Athens General Hospital "G. Gennimatas"
More Information
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Responsible Party: Spyridon Deftereos, Director, Cardiac Catheterization Department, G.Gennimatas General Hospital
ClinicalTrials.gov Identifier: NCT02281305     History of Changes
Other Study ID Numbers: 22977 / 29-08-2014
First Posted: November 3, 2014    Key Record Dates
Last Update Posted: November 3, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
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Inflammation
Infarction
Myocardial Infarction
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
 Vascular Diseases
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents